Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.

BACKGROUND:Point of care tests (POCTs) are increasingly being promoted for guiding the primary medical care of community acquired lower respiratory tract infections (CA-LRTI). POCT development has seldom been guided by explicitly identified clinical need and requirements of the intended users. Appro...

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Main Authors: Micaela Gal, Nicholas A Francis, Kerenza Hood, Jorge Villacian, Herman Goossens, Angela Watkins, Christopher C Butler, RAPP-ID consortium
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2018-01-01
Series:PLoS ONE
Online Access:http://europepmc.org/articles/PMC6070214?pdf=render
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spelling doaj-3135a5228f974254a3de90da550439ef2020-11-25T01:36:42ZengPublic Library of Science (PLoS)PLoS ONE1932-62032018-01-01138e020053110.1371/journal.pone.0200531Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.Micaela GalNicholas A FrancisKerenza HoodJorge VillacianHerman GoossensAngela WatkinsChristopher C ButlerRAPP-ID consortiumBACKGROUND:Point of care tests (POCTs) are increasingly being promoted for guiding the primary medical care of community acquired lower respiratory tract infections (CA-LRTI). POCT development has seldom been guided by explicitly identified clinical need and requirements of the intended users. Approaches for identifying POCT priorities and developing target product profiles (TPPs) for POCTs in primary medical care are not well developed, and there is no published TPP for a CA-LRTI POCT aimed at developed countries. METHODS:We conducted workshops with expert stakeholders and a survey with primary care clinicians to produce a target product profile (TPP) to guide the development of a clinically relevant and technologically feasible POCT for CA-LRTI. RESULTS:Participants with clinical, academic, industrial, technological and basic scientific backgrounds contributed to four expert workshops, and 45 practicing primary care clinicians responded to an online survey and prioritised community-acquired pneumonia (CAP) as the CA-LRTI where a new POCT was most urgently needed. Consensus was reached on a TPP document that included information on the intended niche in the clinical pathway in primary medical care; diagnostic product specification (intended use statement and test concept), and minimum and ideal user specifications. Clinicians minimum requirements of a CA-LRTI POCT included the use of minimally invasive samples, a result in less than 30 minutes, no more than a single preparation step, minimum operational requirements, and detection of common respiratory pathogens and their resistance to commonly prescribed antibiotics. CONCLUSIONS:This multidisciplinary, multistage partnership approach generated a clinically-driven TPP for guiding the development of a new POCT, and this approach as well as the TPP itself may be useful to others developing a new POCT.http://europepmc.org/articles/PMC6070214?pdf=render
collection DOAJ
language English
format Article
sources DOAJ
author Micaela Gal
Nicholas A Francis
Kerenza Hood
Jorge Villacian
Herman Goossens
Angela Watkins
Christopher C Butler
RAPP-ID consortium
spellingShingle Micaela Gal
Nicholas A Francis
Kerenza Hood
Jorge Villacian
Herman Goossens
Angela Watkins
Christopher C Butler
RAPP-ID consortium
Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
PLoS ONE
author_facet Micaela Gal
Nicholas A Francis
Kerenza Hood
Jorge Villacian
Herman Goossens
Angela Watkins
Christopher C Butler
RAPP-ID consortium
author_sort Micaela Gal
title Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
title_short Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
title_full Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
title_fullStr Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
title_full_unstemmed Matching diagnostics development to clinical need: Target product profile development for a point of care test for community-acquired lower respiratory tract infection.
title_sort matching diagnostics development to clinical need: target product profile development for a point of care test for community-acquired lower respiratory tract infection.
publisher Public Library of Science (PLoS)
series PLoS ONE
issn 1932-6203
publishDate 2018-01-01
description BACKGROUND:Point of care tests (POCTs) are increasingly being promoted for guiding the primary medical care of community acquired lower respiratory tract infections (CA-LRTI). POCT development has seldom been guided by explicitly identified clinical need and requirements of the intended users. Approaches for identifying POCT priorities and developing target product profiles (TPPs) for POCTs in primary medical care are not well developed, and there is no published TPP for a CA-LRTI POCT aimed at developed countries. METHODS:We conducted workshops with expert stakeholders and a survey with primary care clinicians to produce a target product profile (TPP) to guide the development of a clinically relevant and technologically feasible POCT for CA-LRTI. RESULTS:Participants with clinical, academic, industrial, technological and basic scientific backgrounds contributed to four expert workshops, and 45 practicing primary care clinicians responded to an online survey and prioritised community-acquired pneumonia (CAP) as the CA-LRTI where a new POCT was most urgently needed. Consensus was reached on a TPP document that included information on the intended niche in the clinical pathway in primary medical care; diagnostic product specification (intended use statement and test concept), and minimum and ideal user specifications. Clinicians minimum requirements of a CA-LRTI POCT included the use of minimally invasive samples, a result in less than 30 minutes, no more than a single preparation step, minimum operational requirements, and detection of common respiratory pathogens and their resistance to commonly prescribed antibiotics. CONCLUSIONS:This multidisciplinary, multistage partnership approach generated a clinically-driven TPP for guiding the development of a new POCT, and this approach as well as the TPP itself may be useful to others developing a new POCT.
url http://europepmc.org/articles/PMC6070214?pdf=render
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